Automatic Self Transcending Meditation (ASTM) in Patients With Dry Eye Disease

NCT03087006 | Unknown DMC

• 1 other identifier: 108461
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with dry eye disease (DED) will be randomized to Automatic Self Transcending Meditation (ASTM) plus Treatment as Usual (TAU) or TAU alone to assess changes in Health-related quality of life (HRQoL). HRQoL is a vital construct focusing on impact of health on quality of life. HRQoL data is used in economic evaluations, a component of health economics that compares the cost and consequences of alternative courses of action. This helps policy-makers make complex financial decisions. Along with HRQoL we will measure changes in extent of depression as well as anxiety. Previously published data lacks information of HRQoL in patients with DED. Through this study we shall attempt to correlate HRQoL in this population and assess if ASTM confers changes in HRQoL along with depressive and anxiety symptoms.

Conditions

Eye Diseases; Quality of Life; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in Health-related quality of life (HRQoL)

  HRQoL is an essential measure of quality of life related to health; it helps physician identify hidden morbidity in clinical care as well as improves patient-physician communications. HRQoL will be measured using time trade-off questionnaire.

  First office visit, Week 0, 4, 6, 8, 12, and 24

Secondary Outcomes (4)

• Visual Function Score

  First office visit, Week 0, 4, 6, 8, 12, and 24

• Depression

  First office visit, Week 0, 4, 6, 8, 12, and 24

• Anxiety

  First office visit, Week 0, 4, 6, 8, 12, and 24

• Dry Eye Assesment

  First office visit, Week 0, 4, 6, 8, 12, and 24

Study Arms (2)

Automatic Self Transcending Meditation

ACTIVE COMPARATOR

Automatic Self Transcending Meditation (ASTM) may help with depression, anxiety, stress, PTSD, and may have a positive impact on quality of life of participants diagnosed with dry eye disease. ASTM is a class of meditation that helps quiet the mind and induces physiological and mental relaxation whilst the eyes are shut. It utilizes a specific sound value (mantra) to draw attention inward and permit the mind to experience a restful but alert state of consciousness.

Other: Automatic Self Transcending Meditation (ASTM)

Treatment as Usual (TAU)

PLACEBO COMPARATOR

Participants continue to receive treatment as usual including dry eye disease medications.

Other: Treatment as Usual

Interventions

Automatic Self Transcending Meditation (ASTM) OTHER

Automatic Self Transcending Meditation (ASTM) is a class of meditation that helps quiet the mind. Research suggests that ASTM helps reduce depression, anxiety, stress, and may improve health related quality of life. Further, ASTM is easier to learn and to teach.

Also known as: Meditation

Automatic Self Transcending Meditation

Treatment as Usual OTHER

Usual Care includes usual care of the participants including dry eye disease medications

Also known as: Primary Care

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• dry eye disease suspects or have mild to severe dry eye disease
• at least between 18 to 75 years of age
• deemed competent such as no language issues or communication barriers, no self-reported or physician diagnosed mental health disorder besides having depressive and anxiety symptoms
• have sufficient hearing to be able to follow verbal instructions and able to sit without physical discomfort for 30 minutes
• willing and able to attend 4 initial ASTM training sessions and at least 80% of follow up sessions
• willing to dedicate 20 minutes twice per day to ASTM practice at their own home.

You may not qualify if:

• actively suicidal as per self-report (scoring 2 or more on item 9 of the PHQ-9) or on assessment by the physician
• they are currently participating in other similar studies
• currently practicing any type of formal meditation techniques regularly
• unable or unwilling to answer survey questions.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

St. Joseph's Hospital, Ivey Eye Institute

London, Ontario, N6G0H8, Canada

Location

Related Publications (7)

• Schein OD, Munoz B, Tielsch JM, Bandeen-Roche K, West S. Prevalence of dry eye among the elderly. Am J Ophthalmol. 1997 Dec;124(6):723-8. doi: 10.1016/s0002-9394(14)71688-5.

  PMID: 9402817 BACKGROUND

• Schaumberg DA, Dana R, Buring JE, Sullivan DA. Prevalence of dry eye disease among US men: estimates from the Physicians' Health Studies. Arch Ophthalmol. 2009 Jun;127(6):763-8. doi: 10.1001/archophthalmol.2009.103.

  PMID: 19506195 BACKGROUND

• Schaumberg DA, Sullivan DA, Buring JE, Dana MR. Prevalence of dry eye syndrome among US women. Am J Ophthalmol. 2003 Aug;136(2):318-26. doi: 10.1016/s0002-9394(03)00218-6.

  PMID: 12888056 BACKGROUND

• Yu J, Asche CV, Fairchild CJ. The economic burden of dry eye disease in the United States: a decision tree analysis. Cornea. 2011 Apr;30(4):379-87. doi: 10.1097/ICO.0b013e3181f7f363.

  PMID: 21045640 BACKGROUND

• Wan KH, Chen LJ, Young AL. Depression and anxiety in dry eye disease: a systematic review and meta-analysis. Eye (Lond). 2016 Dec;30(12):1558-1567. doi: 10.1038/eye.2016.186. Epub 2016 Aug 12.

  PMID: 27518547 BACKGROUND

• Burns JL., Lee RM, Brown LJ. The effect of meditation on self-reported measures of stress, anxiety, depression, and perfectionism in a college population. Journal of College Student Psychotherapy 25(2): 132-144, 2011.

  BACKGROUND

• Elder C, Nidich S, Moriarty F, Nidich R. Effect of transcendental meditation on employee stress, depression, and burnout: a randomized controlled study. Perm J. 2014 Winter;18(1):19-23. doi: 10.7812/TPP/13-102.

  PMID: 24626068 BACKGROUND

MeSH Terms

Conditions

Eye Diseases; Depression; Anxiety Disorders

Interventions

Meditation; Therapeutics; Primary Health Care

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Monali Malvankar, PhD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monali Malvankar, PhD

CONTACT

5196858500; monali.malvankar@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 22, 2017
• Study Start: July 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: August 24, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)